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Don Hribek

• June 03

How Patient Support Programs Can Compliantly Interact with Commercial Teams

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A question we’re often asked is how manufacturer-sponsored patient support programs can compliantly interact with the organization’s sales forces or commercial teams. The fear surrounding non-compliance leaves our clients wondering if there is any information they can safely share with their commercial colleagues.

We asked Archbow team member, Don Hribek, to give us a background overview, and help us identify a compliant path forward for patient support programs. Don shares his experience and expertise in this space with Archbow clients to help them make sense of the new direction manufacturers are taking to meet regulatory requirements when sharing information with commercial teams.

Don joined Team Archbow this year, focusing on supporting quality patient access and care. Learn more about Don here.

What Recent Increased Compliance Requirements Mean for Pharmaceutical Manufacturers’ Patient Support Programs

By Don Hribek

Patient Support Programs have become a near-necessity for manufacturers to assist patients in accessing their medications. Getting patients on therapy is more complicated than ever as payers evaluate new and existing products coming to market. Patient Support programs exist for one purpose – to get patients on their HCP-prescribed therapy; they are not meant to be used by sales or marketing teams as a competitive advantage.

However, sales forces and commercial teams often see the patient support service programs as an extension of their activities and want to be involved in relaying information back to the HCPs. While understandable, the desire for sales teams to be involved can create compliance issues.

Background

Considering the complexities associated with reimbursement and how HUBs can offset those complexities, it is no surprise that patient support programs are becoming more valuable to providers and patients. Although practices may manage some tasks internally and rely on external resources for odd payers or complex cases, there is no denying that the need for dedicated patient support programs continues to grow.

In the past, sales forces viewed patient support services as an entry point to access HCP offices. Sales Representatives wanted to be seen as a resource to provide updates or progress reports on the HCP’s patients sent to the HUB. In some instances, sales forces had regular interactions with patient support agents (Product Navigator, Case Managers, etc.) to obtain updates on de-identified patients.

However, much of that has changed or evolved in recent years.

Increased compliance risks and a growing number of governmental investigations and settlements call into question the practice of pharmaceutical companies’ patient support program activities. This has increased the need to create even more firewalls between patient support programs and commercial sales teams.

Moving Forward

Change is rarely easy. Eliminating all direct interactions between patient support program agents and sales representatives/commercial teams is especially difficult but necessary, in today’s environment. Patient support personnel and commercial field representatives must keep their roles and responsibilities separate, both internally and during interactions with HCPs.

Developing set “rules of engagement” for sales and other commercial teams drives optimal interactions between these stakeholders and the patient support service team. A best practice is to create a governance document and training program for all stakeholders. This process should also include setting clear protocols on how to escalate issues, opportunities, or suggestions to improve the patient experience.

The question remains: for patients currently prescribed a company product by an HCP and enrolled in the patient support program, what information can be shared with the commercial sales team? The answer will entirely depend on each company’s legal, privacy, and compliance professionals to determine the level of detail that can be shared.

The table below details data that can safely be shared with the commercial sales team without creating any HIPAA or PHI issues, along with the data that should never be shared.

The information shared with the sales forces can be viewed through the platforms currently being used by companies, and in some instances, be refreshed throughout the day as updates become available. The availability and frequency of data fields will depend on the technology platforms in use by organizations.

What does all of this mean for manufacturers?

It is now crucial that manufacturers ensure patient support programs are truly patient-focused and appropriately utilized to support the patients who are prescribed a manufacturer’s product. Many commercial teams may benefit from a reminder that patient support programs may not be used to induce, influence, or reward prescribing behavior, or create demand for, sell, or promote any product, service, or program.

That may sound limiting, but there is an upside: Having a dedicated patient support services function allows the sales force to focus on selling a product and prevents the loss of valuable selling time spent updating or troubleshooting patient journey issues.

Creating good standard operating practices/procedures with well-defined, specific guidelines coupled with ongoing training and certification of commercial and sales teams is essential. If your organization would like to better understand how to mitigate the potential negative impacts of compliance, we can help. Our pharmaceutical consulting company team guides manufacturers through the patient support design/redesign process, drafts SOPs, develops training, and implements program launches and modifications. Contact us today to get started.

For additional insights on this topic, you may also enjoy the following blog posts:

Six Strategies for Cross-Functional Collaboration Between Compliance and Access

11 Market Access Questions to Address Prior to Launching Your First Specialty Drug

5 Hurdles to Patient Support Program Success and How to Overcome Them

Archbow Consulting helps pharmaceutical and biotech companies in the USA and Europe design, build, and optimize product distribution and patient access strategies. Archbow was founded by industry veterans to meet a need in the marketplace for consulting options that offer diverse real-world experience, are able to leverage deep connections across the industry, and can also provide actionable strategic guidance. We invite you to learn more about our team, services, and clients’ success, and connect with us via email, LinkedIn or subscribing to this blog which you can do below.

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